Orchestra BioMed Holdings has announced the first patient enrolment in the Virtue trial, the US investigational device exemption (IDE) pivotal trial comparing its Virtue sirolimus angio infusion balloon—Virtue SAB—to the Agent paclitaxel-coated balloon (Boston Scientific), currently the only drug-coated balloon (DCB) US Food and Drug Administration (FDA)-approved for a coronary indication.
The initial cases were completed by the teams at The Christ Hospital Heart & Vascular Institute (Cincinnati, USA) and St Francis Hospital & Heart Center (Roslyn, USA), marking the initiation of the Virtue trial.
Dean Kereiakes (The Christ Hospital Heart & Vascular Institute, Cincinnati, USA) and Allen Jeremias (St Francis Hospital & Heart Center, Roslyn, USA) are co-principial investigators of the trial.
Designed to support regulatory approval of Virtue SAB, the Virtue trial is expected to enrol 740 patients at up to 75 centres in the USA with enrolment completion currently planned for mid-2027.
“Virtue SAB and SirolimusEFR were specifically designed to optimise the dose, delivery, uptake and extended release of sirolimus without the limitations of a drug coating on the balloon surface. A substantial body of clinical evidence from drug-eluting stent studies has established sirolimus and its analogues as the gold-standard drug for promoting vessel healing and preventing restenosis following interventional procedures,” said Jarrod D Frizzell (The Christ Hospital Health Network, Cincinnati, USA). “The Virtue trial will allow us to evaluate the performance of this fundamentally different approach to delivering sirolimus, which has shown promising results in a prior pilot clinical study in coronary ISR treatment, in direct comparison to the Agent paclitaxel-coated balloon.”
Virtue SAB is designed to deliver a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon that protects the drug in transit and helps overcome certain limitations of DCBs. SirolimusEFR is designed to enable enhanced tissue uptake and extended release of therapeutic levels of sirolimus through the critical healing period, exceeding previously published target tissue concentrations of proven drug-eluting stents.
Jeremias commented: “Drug coated balloons offer a promising alternative to drug-eluting stents for the treatment of coronary indications such as coronary ISR. Virtue SAB and SirolimusEFR are designed to go beyond DCBs with the goal of optimising drug dosing, tissue uptake and extended drug bioavailability at the site of treatment. Our team at St Francis is excited to play a leadership role in the Virtue trial which will evaluate this differentiated, non-coated drug-delivery system head-to-head versus the current market leading DCB.”
In the multicentre SABRE pilot study, Virtue SAB demonstrated promising clinical results for the treatment of single-layer coronary ISR including 12-month target lesion failure of 2.8%, zero target lesion revascularisations from 12-month follow-up through 36-month follow-up; and six-month late lumen loss of 0.12mm.
Virtue SAB has FDA breakthrough device designation for the treatment of coronary ISR, as well as for coronary small vessel disease and below-the-knee peripheral artery disease. Orchestra BioMed estimates the total global market opportunity for drug-eluting balloons to be over $10 billion annually.
